Tracoe Purofoam-T Large

Basic Information

• Brand Name: Tracoe Purofoam-T Large
• Primary DI: 05060031485424
• Version / Model: CR4555
• Company Name: BRIGHTWAKE LIMITED
• Labeler DUNS: 226502201
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-10-08
• Public Version: 1
• Public Version Date: 2025-10-16
• Public Version Status: New
• Public Device Record Key: e765c6f2-16c5-4b12-a1ff-2e6f2cf3cc4b

Device Description

Non-Adhesive Tracheostomy Dressing

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	878.4018	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15624	Tracheostomy tube dressing	A pad designed to conform around a tracheostomy tube at its insertion site to provide protection for the skin and/or to absorb secretions. It is typically designed with a slit or hole to facilitate tube fitting. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060031485424	GS1
Package	05060031485431	GS1	Retail	10	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Width	8	Centimeter
Length	8	Centimeter
Height	0.5	Centimeter